Presentation on theme: "IRB Approval for FMT What does an IRB look for in FMT Protocols?"— Presentation transcript:

3IRB Review of an FMT ProtocolIs FMT human research?Is an IND requiredIs the proposal scientifically valid?Are the risks minimized?Will potential participants receive sufficient information to make an informed decision?Will the privacy of the participants and donors be protected?

4What Constitutes Research?OHRPSystematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledgeFDAAny experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA...or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. food and color additives, drugs for human use, medical devices for human use, biological products for human use, …

5Yes if any of these applyIs FMT Human Research?Yes if any of these applyNo if all of these applyAn IND is requiredNo IND is requiredSystematic collection of data for analysisJust for treatmentFor publicationNot for main purpose of publication

8IRB Review of an FMT ProtocolIs FMT human research?Is an IND requiredIs the proposal scientifically valid?Are the risks minimized?Will potential participants receive sufficient information to make an informed decision?Will the privacy of the participants and donors be protected?

18FMT for C. difficile FDA Guidance July 2013Enforcement discretion policy does not extend to other uses of FMTFDA will continue to work with any sponsors who wish to submit INDs for this use (C. difficile treatment) of FMT

20Is and IND Required for FMT?Yes ifMaybeNo ifThe treatment isn’t for C. difficileThe treatment is a research study for C. difficile, not primarily for clinical careThe treatment is for C. difficile for clinical care

24IRB Review of an FMT ProtocolIs FMT human research?Is an IND requiredIs the proposal scientifically valid?Are the risks minimized?Will potential participants receive sufficient information to make an informed decision?Will the privacy of the participants and donors be protected?

27IRB Review of an FMT ProtocolIs FMT human research?Is an IND requiredIs the proposal scientifically valid?Are the risks minimized?Will potential participants receive sufficient information to make an informed decision?Will the privacy of the participants and donors be protected?

29IRB Review of an FMT ProtocolIs FMT human research?Is an IND requiredIs the proposal scientifically valid?Are the risks minimized?Will potential participants receive sufficient information to make an informed decision?Will the privacy of the participants and donors be protected?

30Elements of Informed Consent OHRPThis is researchBenefitsPurposeAlternativesDurationConfidentialityProcedure detailsCompensation for injuryExperimental proceduresWhom to contactRisksVoluntary

31IRB Review of an FMT ProtocolIs FMT human research?Is an IND requiredIs the proposal scientifically valid?Are the risks minimized?Will potential participants receive sufficient information to make an informed decision?Will the privacy of the participants and donors be insured?

32FMT Donor Registry Sarah Location: New York City, NY, USAGender: FemaleAge: 49Have Donated Previously: NoLiability Agreement Required: YesCost: All fees associated with required testing & negotiable ‘per donation’ feeWhy Donating: I believe in the theory of FMT and have been a pristine eater all my life so I figure I can help others.thepowerofpoop.com

35IRB Review of an FMT ProtocolIs FMT human research?Is an IND requiredIs the proposal scientifically valid?Are the risks minimized?Will potential participants receive sufficient information to make an informed decision?Will the privacy of the participants and donors be insured?

36IRB Approval for FMT SummaryThe divide between FMT for clinical practice and research is complicatedThe FDA rules on INDs for FMT are not finalizedThe usual IRB concerns for human research studies apply for the:RecipientDonor